The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1353-2024·Announced 2024-04-10

Mojo 2 Full Face Vented Mask Recalled: Magnet Contraindications Updated

SleepNet Corporation is recalling 2,787 units of the Mojo 2 Full Face Vented Mask due to updates needed for contraindications and warning language regarding magnets in the device. Worldwide distribution.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as FDA Class I by the agency. Per the severity rubric, FDA Class I recalls must receive a minimum score of 4 (Severe), as they indicate a potentially serious hazard requiring immediate corrective action.

Plain-English summary

SleepNet Corporation is recalling 2,787 units of the Mojo 2 Full Face Vented Mask across all sizes due to the presence of magnets in the device. The U.S. Food and Drug Administration classified this as a Class I recall.

The recall involves updates to the contraindications and warning language on the product to address hazards associated with the magnets contained in the masks. The manufacturer determined that the existing contraindications and warnings required revision.

The affected masks have been distributed worldwide, including throughout the United States and to more than 40 countries including Austria, Brazil, France, Germany, Japan, and others.

Users of the Mojo 2 Full Face Vented Mask should review the updated contraindication and warning information provided by SleepNet Corporation. Consumers with concerns about their device should contact the manufacturer or consult their healthcare provider.

The recalled product

Product
Mojo 2 Full Face Vented Mask, All Sizes
Manufacturer
SleepNet Corporation
Category
Medical Device — CPAP Equipment
Hazard
Affected units
2,787

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All UDI-DI
  • All Lot Numbers.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by SleepNet Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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